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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

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ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number ASKU
Device Problem Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2015
Event Type  malfunction  
Manufacturer Narrative
No sample or lot number information has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested, but no additional information is anticipated.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that particulates were detected inside of the viscoelastic solution.Procedure details and patient impact information is unknown.Additional information has been requested.Additional information was received which confirmed that the particulates were noted during multiple procedures.The particulates were removed during each respective procedure with no further information available.
 
Manufacturer Narrative
All batches are released according to the required specifications and all testing results were within specification for this batch.A small amount of silicone was found in the initial samples.Our lab has retested a reference sample of this batch and all results conformed to the specifications for the tested parameters.To date, no customer sample was returned for evaluation so no further investigation towards the actual origin of the reported particulates can be performed.We can however inform you that a 100% visual inspection process of all filled syringes is performed to remove syringes with large silicone droplets.The silicone oil used is manufactured and tested in compliance with good manufacturing practices at an iso certified facility.Medical grade silicone is used to coat all types of stoppers and syringe barrels to permit proper function of the syringe.The low levels of silicone oil do not elicit local ocular or systemic toxicity.The root cause of this reported event is inconclusive as the reserve sample product met specifications.(b)(4).
 
Event Description
Additional information was received on a returned questionnaire confirming that there was no patient impact.
 
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Brand Name
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Type of Device
AID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE  B-2870
Manufacturer (Section G)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE   B-2870
Manufacturer Contact
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5242817
MDR Text Key32137385
Report Number3002037047-2015-00574
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue NumberASKU
Device Lot Number15F03V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/29/2015
Initial Date FDA Received11/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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